NCT00787605已完成4 期
An 8-week Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and < 200 mm Hg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Amlodipine
Active Comparator
Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks
干预措施: Amlodipine (Drug)
Aliskiren / HCTZ
Experimental
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
干预措施: Hydrochlorothiazide (HCTZ) (Drug)
Aliskiren / HCTZ
Experimental
Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
干预措施: Aliskiren (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline and Week 8
次要结局
- Biomarker Measurements(Baseline and Week 8)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline and Week 8)
- Evaluate the Safety and Tolerability(after 8 weeks of treatment)
- Percentage of Responders(Week 8)
- Percentage of Patients Achieving Blood Pressure Control(after 8 weeks of treatment)
研究者
研究点 (1)
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